Trials / Completed
CompletedNCT00723346
Administration of Allogenic Red Blood Cells Loaded L-asparaginase in Cases of Relapse of Acute Lymphoblastic Leukaemia
Administration of Allogenic of Red Blood Cells Loaded L Asparaginase in Acute Lymphoblastic Leukemia Relapse.
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- ERYtech Pharma · Industry
- Sex
- All
- Age
- 1 Year – 55 Years
- Healthy volunteers
- Not accepted
Summary
Primary objective : * To explore the relation between 3 doses of GRASPA and duration of asparagine depletion (\< 2µmol/l) Secondary objective : * Pharmacokinetic / Pharmacodynamic parameters * toxicity * Study duration : 2 years * Study treatment : Red blood cells loaded with L asparaginase versus native L asparaginase * Associated treatments : COPRALL chemotherapy * Randomization : centralised randomisation on scratching list
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GRASPA | 50 UI/Kg |
| BIOLOGICAL | GRASPA | 100 UI/Kg |
| BIOLOGICAL | GRASPA | 150 UI/Kg |
| DRUG | native L asparaginase | 10000UI/m2, 14 infusions during 4 chemotherapy cycle |
Timeline
- Start date
- 2006-01-01
- Primary completion
- 2008-08-01
- Completion
- 2009-03-01
- First posted
- 2008-07-28
- Last updated
- 2012-01-11
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT00723346. Inclusion in this directory is not an endorsement.